Recall Z-0480-2011
Becton Dickinson & Co. · initiated August 13, 2010
Product
GasPak EZ Large Incubation Container, a component of the GasPak EZ Gas Generating Container System, catalog # 260672, labeled in part ***Becton Dickinson and Company Loveton Circle Sparks, MD 21152 USA***
Codes / lots: Batch No. 7110573
Reason for recall
In vitro diagnostic reagent containers may be defective and could cause incorrect test results in patient samples.
FDA-determined cause: Nonconforming Material/Component
Action taken
BD Diagnostic Systems issued an Urgent Product Recall letter dated August 2010 to consignees. Consignees were advised of the defect and were requested to discard product for replacement. Distributors were additionally requested to provide distribution lists of end users for direct BD notification. Accounts were requested to return a response form. BD Customer Service can be contacted at 800 675-0908, and BD Technical Services can be contacted at 800-638-8663.
Details
- Recall number
- Z-0480-2011
- Initiated
- August 13, 2010
- Posted by FDA
- November 26, 2010
- Terminated
- January 5, 2011
- Product code
- KZJ – Device, Gas Generating
- Quantity
- 496 units
- Distribution
- Worldwide Distribution: USA and the countries of Australila, Belgium, Canada, India, Mexico, New Zealand. Singapore, and South Korea,
- Recalling firm
- Becton Dickinson & Co., Sparks, MD